FDA Issues Comprehensive Regulatory Update

May 20, 2024

The United States Food and Drug Administration (FDA) has issued its weekly comprehensive regulatory update, which can be read below.

The latest from FDA

Public health emergency response and other updates from FDA since our last MCMi email include:

Updates on Highly Pathogenic Avian Influenza (HPAI) (also see information below)
May 15, 2024: Podcast: Considerations for Drug Products that Contain Nanomaterials
May 15, 2024: FDA Voices: Protecting and Advancing the Health of Women Through Policy, Research, Education and Outreach
May 13, 2024: FDA’s Office of Science and Engineering Laboratories launched an improved online Regulatory Science Tool (RST) Catalog to enhance search and browse capability as well as allow for long-term growth in published tools.
May 13, 2024: FDA added 191 devices to the list of artificial intelligence and machine learning (AI/ML)-enabled devices legally marketed in the United States by 510(k) clearance, granted De Novo request, or premarket approval.
May 13, 2024: FDA issued a safety communication to warn patients, caregivers, and health care providers not to use Cue Health’s COVID-19 tests due to an increased risk of false results.
May 9, 2024: Charging medical devices the wrong way can lead to overheating, which can result in fires, minor injuries, or serious burns. FDA offers tips to help charge medical devices safely.
May 8, 2024: The U.S. Environmental Protection Agency (EPA), FDA, and the U.S. Department of Agriculture (USDA) issued a Joint Regulatory Plan for Biotechnology
May 8, 2024: New web page: Facts about FDA and Animal Welfare, Testing & Research 
May 6, 2024: FDA and the National Institutes of Health (NIH) are seeking comment on a draft glossary of clinical research terms related to innovative clinical trial design (also see information below)
Recent reports published by FDA:

2023 Drug Trials Snapshots Summary Report (FDA Center for Drug Evaluation and Research [CDER])
2023 Office of New Drugs (OND) Annual Report (CDER)
Office of Translational Sciences (OTS) 2023 Annual Report (CDER)

More FDA press announcements

HPAI response updates

Highly pathogenic avian influenza (H5N1) in dairy cows

In a May 10 update, FDA confirmed that all 297 samples from FDA’s national survey of retail dairy products were found to be negative for viable highly pathogenic H5N1 avian influenza (H5N1 HPAI) virus. On May 20, for continued transparency, FDA provided additional information on our retail sample survey.
While FDA collected the 297 samples at retail locations in 17 states, these retail samples represent products produced at 132 processing locations in 38 states. Retail samples were collected between April 18-22, 2024, and represent a snapshot in time. This testing did not detect any live, infectious virus.

Read more: Updates on HPAI from FDA

Learn more from FDA and our federal partners:

May 16, 2024: Updates on H5N1 Beef Safety Studies (USDA)
May 14, 2024: Influenza A Virus Wastewater Data (CDC)
May 10, 2024: Fact Sheet: USDA, HHS Announce New Actions to Reduce Impact and Spread of H5N1
Questions and answers regarding milk safety and egg safety during HPAI outbreaks (FDA)
HPAI Detections in Livestock (USDA)
Current H5N1 Bird Flu Situation in Dairy Cows (CDC)
How CDC is monitoring influenza data among people to better understand the current avian influenza A (H5N1) situation (CDC)

Consumer information on milk safety from FDA:

Keeping Your Milk Safe From the Grass to the Glass - A look at what makes your milk and dairy safe, and the 100-year history behind it
The Dangers of Raw Milk: Unpasteurized Milk Can Pose a Serious Health Risk

NIH and FDA seek comment

Draft glossary of clinical research terms related to innovative clinical trial design

On May 6, 2024, FDA and NIH published a request for information (RFI) seeking public comments on a proposed glossary of clinical research terminology. This glossary is intended to facilitate communication within the clinical research community by helping establish a common vocabulary to more uniformly characterize clinical research. FDA and NIH identified and developed definitions for 37 terms related to innovative clinical study designs. The public comment period will be open through June 24, 2024.

View the RFI

Emergency Use Authorization (EUA) updates

EUA quick links

Emergency Use Authorization - about EUAs, and links to current EUAs
EUAs for Drugs and Non-Vaccine Biological Products (CDER)
EUAs for Medical Devices (CDRH)
COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
Historical Information about Device EUAs

Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens - July 30 - August 1, 2024

Events

May 21, 2024: FDA Drug Topics: Fraudulent Drugs: You’re Using What? - Division of Drug Information continuing education (CE) webinar
May 23, 2024: Medical Device Sterilization Town Hall – Sterilization Method Selection for New and Existing Devices (virtual)
May 29-30, 2024: Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development, with tracks for drugs, devices and biologics (College Park, MD or virtual)
May 30, 2024: Real-World Evidence Webinar Series: Considerations Regarding Non-Interventional Studies for Drug and Biological Products, hosted by the Reagan-Udall Foundation, in collaboration with FDA
June 5, 2024: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines. (rescheduled from May 16, 2024)
June 5, 2024: Webinar - Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances - If you have questions about these draft guidances that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by May 24, 2024, to be considered for the discussion.
June 13, 2024: Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees (virtual listening session) Also see: Advisory Committees Give FDA Critical Advice and the Public a Voice
June 17-18, 2024: Partnership for DSCSA Governance (PDG)/FDA Joint Public Meeting: DSCSA Stabilization Period Midway Checkpoint (Washington, DC or virtual) - The Partnership for DSCSA Governance (PDG) and FDA are hosting a joint public meeting on the Drug Supply Chain Security Act(DSCSA) implementation and stabilization efforts. This free meeting serves as a checkpoint midway in the stabilization period, affording industry, FDA and others an opportunity to share stabilization progress that has been made, stabilization activity that remains and areas of remaining concern.
June 27, 2024: Webinar – Final Guidance: Remanufacturing of Medical Devices
July 30 - August 1, 2024: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - Save the date, and pre-register by June 30, 2024 to attend in-person, or by July 12, 2024 to attend virtually.

More events: FDA Meetings, Conferences and Workshops

Information for industry and health care providers

Guidance and updates for industry

On May 9, 2024, FDA issued the final guidance: Remanufacturing of Medical Devices as part of ongoing efforts to help distinguish between remanufacturing and servicing. This guidance clarifies whether activities performed on devices are likely "remanufacturing," which differs from servicing activities such as maintenance and repair. This clarification is intended to help ensure consistency and a better understanding of the regulatory requirements applicable to remanufacturers. Additionally, the guidance recommends information to be included in the labeling of reusable medical devices to help ensure their continued quality and safety during servicing. On June 27, 2024, FDA will host a webinar for those interested in learning more about the final guidance.

Expiration date extension

You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions. Recent extension:

ImmuView COVID-19 Antigen Home Test (CTK Biotech, Inc.)

Visit At-Home OTC COVID-19 Diagnostic Tests and At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions for more information about expiration date extensions of at-home COVID-19 tests.

In case you missed it

Quick COVID-19 resources

Check expiration date extensions for your COVID-19 tests
Get the latest on COVID-19 vaccines
Know your treatment options for COVID-19

What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ.

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 650 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.

Q&A with FDA podcast
In this podcast series, FDA’s Division of Drug Information answers some of the most commonly asked questions received by FDA. Previous episodes include conversations about drug shortages, expanded access, avoiding medication scams, and much more.

NYSDA Publications